April 20, 2022 | By Mary Kohler in Law360
Medical conferences fuel the development of new therapies. Research professionals share their results and health care professionals learn in the process.
Medical conferences, however, also involve exhibit halls and other events where products are promoted. And these activities have caught the attention of both the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services' Office of Inspector General.
As medical conferences return in person after a two-year hiatus, staff training may have faded. In addition, recent government activity touching on these events could signal increased enforcement risk. This article identifies potential impacts for life science stakeholders and discusses ways to manage the increased risk.
The FDA's Recent Activity
Last summer, the FDA finalized its "intended use" rule. Under this rule, a company can be liable for misbranding if it intentionally markets a new product, or a new use that is beyond an existing product's label, without FDA approval. The preamble identifies evidence the FDA will use to assess a company's intent.[1]
The FDA says it merely formalized existing practice, but experts debate whether the new intended-use rule constitutes an interpretation shift. This debate centers around the FDA's decision not to include protection for sharing truthful, nonmisleading information that is beyond a product's label.
The full impact of the new intended-use rule remains to be seen. But the rule does signal the FDA's intent to scrutinize company promotional activity based on the evidence and examples it provided in the preamble. And its follow-up actions appear to be consistent with this intent.
While the FDA was publishing the intended-use rule, its Office of Prescription Drug Promotion began conducting a study of medical conferences. One component of this study focuses on 12 large medical conferences. Health care professionals participants are enrolled within seven days of attending one of these conferences and asked to recall messaging they heard while there.
According to the Federal Register notice, the study will inform the OPDP's review of booth panels.[2] But it will also gather data the intended-use rule identifies as evidence of intent.
Potential Impact: Established Companies and Promoted Products
At a high level, a company's approach to exhibit booth discussions likely remains unchanged — staff should be trained on what they can discuss and refer what they can't for later follow-up by scientific experts. Considering the environment, however, internal review teams may want to analyze booth materials and promotional messaging with heightened care and an eye toward the FDA potentially narrowing its lens.
Staff retraining on basics might also be needed. While experienced staff should have some degree of muscle memory, two years is still a long time. And training that drills deeper on content may be wise where nuance drives the determination of whether a statement constitutes a claim.
Finally, products in large, competitive markets may face heightened risk, as they may be within the study's focus, and it is unclear whether the results will be shared with the U.S. Department of Justice for enforcement purposes.
On the one hand, the DOJ would likely be challenged to construct a concrete theory based on message recall studies, which are notoriously imperfect. On the other, defending an allegation would still be more difficult if a significant number of attendees were left with the same misimpression about what they saw and heard.
Potential Impact: Research Companies and Scientific Discussions
The FDA's recent activity should represent less change for scientific discussions. Still, the OPDP has kept a steady eye on research activities, issuing at least five letters for preapproval promotion since 2017. The most recent of these was a February warning letter to CytoDyn Inc.[3]
A few notable takeaways from these letters and the new intended-use rule are:
A product's investigational nature must be made clear, and this can be undercut by company statements and booth panels, as well as a booth's location in the exhibit hall.
An example in the intended-use rule preamble endorses limited sharing of truthful, nonmisleading clinical trial data with investigators, but medical conference attendees are a broader audience and the FDA still considers conclusory safety and efficacy statements to be claims.
Products for serious disease may be at higher risk, with two letters citing vulnerable patient populations and the CytoDyn letter criticizing misstatements related to COVID-19.
Companies that sponsor medical booths should follow the OPDP letters and ensure staff can execute on the specialized requirements for scientific discussions to guard against an allegation of preapproval promotion.
Potential Impact: Modest Meals and Events
In late 2020, the OIG issued a special fraud alert to identify speaker program practices it considers problematic.[4] Although the special fraud alert focuses primarily on arrangements with speakers and the rationale for conducting programs, the OIG also weighs in on the food and drink. Specifically, it says providing free alcohol increases risk. The Pharmaceutical Research and Manufacturers of America and the Advanced Medical Technology Association have updated their codes in response.[5]
Although the special fraud alert applies narrowly to speaker programs, it's not difficult to imagine the OIG or the DOJ trying to extrapolate these views to other events, many of which occur at medical conferences. To manage this risk, careful up-front analysis and execution monitoring are pivotal.
Key Takeaways
As medical conferences resume in person, landscape changes suggest increased risk. To manage it:
Consider refresh training for staff.
This can counteract pandemic-related fading and prepare staff for increased scrutiny of booth activity. To facilitate skillful execution in the sometimes-chaotic environment of an exhibit hall, contextualize nuts-and-bolts booth training with meaningful examples that tie in product messaging, fair balance and other important safety information.
Carefully assess content, messaging and execution controls for exhibit booths.
Given the uncertainty surrounding the intended-use rule, some activities — including disseminating reprints and answering questions with truthful, nonmisleading information — may carry more risk than previously thought.
This risk underscores the need for quality training, as it is difficult to place effective controls around live discussions and the FDA's study may capture instances of staff's incorrect execution. Providing booth staff and attendees with clear written materials would also help to ensure key information is communicated accurately and understood.
Have a framework to manage the unique risk of preapproval promotion in scientific booths.
That framework should address the FDA's key concerns. This includes: (1) being clear the products are investigational; (2) presenting data factually without making conclusory statements about safety and efficacy; and (3) describing important study limitations, i.e., telling the whole story.
Pay attention to the events.
Internal teams should carefully review any events the company plans to conduct or sponsor in connection with the medical conference, especially where food and alcohol are offered. This review should ensure the amounts are modest, and the event plans conform to the relevant industry code. Critically assess how the event might look if taken out of context. And make sure execution follows the plan.
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Mary Kohler is founder and principal at Kohler Health Law PC.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
[1] Regulations Regarding "Intended Uses," 86 Fed. Reg. 41383 (Aug. 2, 2021).
[2] Medical Conference Attendees' Observations About Prescription Drug Promotion, 86 Fed. Reg. 37160 (Jul.13, 2021).
[3] Warning Letter to CytoDyn, Inc., Food and Drug Administration Office of Prescription Drug Promotion (Feb. 11, 2022).
[4] Special Fraud Alert: Speaker Programs, Department of Health and Human Services Office of Inspector General (Nov. 16, 2020).
[5] Code on Interactions with Health Care Professionals, Pharmaceutical Research and Manufacturers of America (effective Jan. 1, 2022); and AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (effective Jun. 1, 2022).
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